Skirted Hernia Repair Device

ABSTRACT

The present disclosure relates to skirted hernia repair devices which includes at least a first mesh layer having a first side, a second side, and an outer peripheral edge, a skirt mesh layer positioned on the first side of the first mesh layer, the skirt mesh layer having an inner peripheral edge defining an opening in the skirt mesh layer, and, at least one reinforcement member that prevents the skirt mesh layer from inverting.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16,421,623 filed May 24, 2019, which is a continuation of U.S. patentapplication Ser. No. 14/453,640 filed Aug. 7, 2014, which claims thebenefit of and priority to U.S. Provisional Patent Application No.61/883,450, filed Sep. 27, 2013, the entire disclosure of which isincorporated by reference herein.

BACKGROUND Technical Field

The present disclosure relates to hernia repair devices and, moreparticularly, to reinforced skirted mesh for use in hernia repair.

Background of Related Art

Hernias may be caused by defects in the muscle layer of the abdomen.Historically, attempts to reconstruct the abdominal wall muscles havebeen associated with a high recurrence rate.

Implantable devices for repairing hernia have been known for many years.They may be used to repair damaged tissue and to provide structure forsupporting surrounding tissue.

The most basic form of device that can be used for hernia repair is apiece of mesh or any other flexible flat material that is strong enoughto be affixed to the surrounding damaged tissue.

The key objective of a hernia repair procedure is to patch the herniadefect and to reinforce the surrounding weak muscle layer.

A number of mesh designs and techniques have been introduced to allowsurgeons to improve the outcome of hernia repair procedures and to avoidsome of the common complications.

Skirted hernia repair devices have become somewhat popular because theyoffer added strength and a lower recurrence rate, as compared to theolder non-skirted repair devices.

However, the major challenge presented by the skirted hernia repairdevices is the difficulty of maintaining the skirted repair device flatin the field, until it is properly secured to the surrounding tissue.More specifically, skirted hernia repair devices may be easily inverted,i.e., turned inside-out, prior to and/or during implantation, and morespecifically, while a surgeon attempts to secure the skirted device tothe tissue.

It would be beneficial to provide reinforced skirted hernia repairdevices that are less likely to be inverted prior to and/or duringimplantation and more specifically, while a surgeon attempts to securethe skirted device to the tissue.

SUMMARY

In accordance with one embodiment of the present disclosure, a skirtedhernia repair device having multiple skirted sections is provided. Theskirted hernia repair device includes a first mesh layer, a skirt meshlayer and at least one reinforcement member. The first mesh layerincludes at least a first side, a second side, and an outer peripheraledge. The skirt mesh layer is positioned on the first side of the firstmesh layer, and the skirt mesh layer includes an outer peripheral edgeand an inner peripheral edge. The inner peripheral edge of the skirtmesh layer defines an opening in the skirt mesh layer. At least onereinforcement member connects the first mesh layer to the skirt meshlayer. The reinforcement member is positioned near the inner peripheraledge to prevent the skirt mesh layer from inverting.

In another embodiment, a skirted hernia repair device is described whichincludes a first planar mesh layer, a skirted section, and a pluralityof reinforcement members. The first planar mesh layer has a first side,a second side and an outer peripheral edge. The skirted section islocated on the first side of the first planar mesh layer near the outerperipheral edge. The plurality of reinforcement members connect aportion of the pocket to the first planar mesh layer to prevent thepocket from inverting.

Methods of using the skirted hernia repair devices are also described.In one embodiment, a method for repairing a tissue defect is describedwhich includes: providing a skirted hernia repair device, positioningthe skirted hernia repair device within a tissue defect such that afirst mesh layer extends across the defect; and, securing the skirtedhernia repair device to tissue. The skirted hernia repair deviceincludes a first mesh layer, a skirt mesh layer, and at least onereinforcement member that connects the first mesh layer to the skirtmesh layer to prevent the skirt mesh layer from inverting. The firstmesh layer includes a first side, a second side, and an outer peripheraledge. The skirt mesh layer is positioned on the first side of the firstmesh layer; the skirt mesh layer includes an inner peripheral edgedefining an opening. At least one reinforcement member that connects thefirst mesh layer to the skirt mesh layer to prevent the skirt mesh layerfrom inverting.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the present disclosure are described herein withreference to the drawings wherein:

FIGS. 1A and 1C are each a top view of a prior art skirted hernia repairdevice;

FIG. 1B is a side view of the prior art skirted hernia repair devicedepicted in FIG. 1A;

FIGS. 2A and 2B are each a top view of at least one embodiment of askirted hernia repair device in accordance with the present disclosure;

FIG. 2C is a side view of the embodiment depicted in FIGS. 2A and 2B;

FIG. 3A is a top view of at least one embodiment of a skirted herniarepair device in accordance with the present disclosure;

FIG. 3B is a side view of the embodiment depicted in FIG. 3A;

FIG. 4A is a top view of at least one embodiment of a skirted herniarepair device in accordance with the present disclosure;

FIG. 4B is a side view of the embodiment depicted in FIG. 4A;

FIG. 5 is a side view of one embodiment of a skirted hernia repairdevice in accordance with the present disclosure;

FIG. 6 is a side view of one embodiment of a skirted hernia repairdevice in accordance with the present disclosure; and,

FIG. 7 is a side view of one embodiment of a skirted hernia repairdevice in accordance with the present disclosure.

DETAILED DESCRIPTION

The present disclosure describes skirted hernia repair devices. The term“hernia repair devices” is not intended to be limited to devicessuitable strictly for hernia repair but rather is intended to includeany procedure, i.e., open, laparoscopic, endoluminal, intravaginal,NOTES, etc., for the repair of hernias, prolapses, fistulas, stomas, andthe like. In particular embodiments, the skirted repair devicesdescribed herein may be used in intraperitoneal onlay procedures, andmore particularly, open intraperitoneal onlay procedures.

Turning now to the figures, embodiments of the present disclosure aredescribed in detail with reference to the figures wherein like referencenumerals identify similar or identical elements.

FIGS. 1A-1C show a prior art skirted hernia repair device 100. Thedevice includes a first mesh layer 110 suitable for extending across atissue opening and a skirt mesh layer 120 having an inner peripheraledge 125 which defines opening 127. Outer peripheral edge 116 of firstmesh layer 110 is attached to outer peripheral edge 126 of skirt meshlayer 120 by seam 130. Pocket 140 is formed between first mesh layer 110and skirt mesh layer 120, wherein pocket 140 extends from innerperipheral edge 125 of skirt mesh layer to seam 130 and/or outerperipheral edge 126 of skirt mesh layer 120. As one skilled in the artmay appreciate, in FIG. 1B, skirt mesh layer 120 is shown in aconfiguration which is spaced apart from first mesh layer 110 to betterillustrate pocket 140, but is not intended to suggest that skirt meshlayer 120 is permanently configured in this manner.

As illustrated in FIG. 1C, fastening device 150 may be used to secureskirted hernia repair device 100 to tissue. During implantation, in anopen or laparoscopic procedure, a patient's tissue may prevent directvisualization of fastening device 150 and/or skirted hernia repairdevice 100. In such instances, a surgeon may simply slide fasteningdevice 150 laterally across first mesh layer 110 (as indicated by thearrow) and into pocket 140 until fastening device 150 gets caught orsnagged on seam 130 and/or outer peripheral edges 116, 126 of eitherlayer of the device 100. At which time, the surgeon may fire fasteningdevice 150 and deliver a fastener (not shown) in the vicinity of pocket140 and through device 100, thereby securing device 100 to the tissue inthe vicinity of pocket 140 and/or outer peripheral edge 116, 126 ofeither layer of device 100. However, in some instances as illustrated inFIG. 1C, skirt mesh layer 120 may be inverted or turned inside out whenfastening device 150 is slid laterally across first mesh layer 110 andinto pocket 140. If inverted, fastening device 150 may not catch or snagon seam 130 and/or outer peripheral edges 116, 126 of either layer ofdevice 100. Thus the surgeon can not determine the proper position offastening device 150 relative to the skirted hernia repair device 100.As a result of the inverted pocket or mesh, and without directvisualization, it may be difficult for the surgeon to know when to firefastening device 150.

FIGS. 2A-2C depict a skirted hernia repair device 200 of the presentdisclosure wherein pocket 240 and/or skirt mesh layer 220 is reinforcedby at least one reinforcement member 260 a-j which is preferably locatedin the vicinity of inner peripheral edge 225 to prevent skirt mesh layer220 and/or pocket 240 from inverting. Skirted hernia repair device 200includes a first mesh layer 210 suitable for extending across a tissueopening and a skirt mesh layer 220 having an inner peripheral edge 225which defines opening 227. Outer peripheral edge 216 of first mesh layer210 is attached to outer peripheral edge 226 of skirt mesh layer 220 byseam or fold 230. Pocket 240 is formed between first mesh layer 210 andskirt mesh layer 220, wherein pocket 240 extends from inner peripheraledge 225 of skirt mesh layer to seam or fold 230 and/or outer peripheraledge 226 of skirt mesh layer 220. The skirt mesh layer may extend alongthe entire periphery or only a portion of the peripheral edge 225 of thefirst mesh layer 210.

As further depicted in FIGS. 2A and 2C, skirted hernia repair device 200may include a plurality of reinforcement members 260 a-j which arepositioned around inner peripheral edge 225 of skirt mesh layer 220 toform distinct skirt sections 280 a-j.

As illustrated in FIG. 2B, fastening device 250 may be used to secureskirted hernia repair device 200 to tissue. During implantation, in anopen or laparoscopic procedure, a patient's tissue may prevent directvisualization of fastening device 250 and/or skirted hernia repairdevice 200. In such instances, a surgeon may simply slide fasteningdevice 250 laterally across first mesh layer 210 and into pocket 240until the distal end of fastening device 250 gets caught or snagged onseam or fold 230 and/or outer peripheral edges 216, 226 of either layerof the device 200. At which time, the surgeon may fire fastening device250 and deliver a fastener (not shown) in the vicinity of pocket 240 andthrough device 200, thereby securing device 200 to the tissue in thevicinity of skirt mesh layer 220 and/or outer peripheral edge 216, 226of either layer of device 200. As further illustrated in FIG. 2B,reinforcement members 260 a-j of skirted hernia repair device 200 secureskirt mesh layer 220 to first mesh layer 210 intermittently around innerperipheral edge 225 forming skirt sections 280 a-j and preventing skirtmesh layer 220 and/or pocket 240 from being inverted prior to and/orduring implantation. A more stable pocket 240 enhances a surgeon'sability to identify the proper placement of a fastener to secure device200 and into the tissue. As a result, recurrence rates decrease due tomore stable implants and surgical time decreases due to more efficientprocedures.

As depicted in FIG. 2C, reinforcement members 260 d, 260 f attach orconnect first mesh layer 210 to skirt mesh layer 220 in the vicinity ofinner peripheral edge 225. In embodiments, as further depicted in FIG.2C, reinforcement members 260 d, 260 f may be positioned on top of skirtmesh layer 220 and extend through pocket 240 to connect to first meshlayer 210. In embodiments, as further depicted in FIG. 2, reinforcementmembers 260 may be filaments which can be woven, braided, knitted,non-woven, and the like, to attach skirt mesh layer 220 to first meshlayer 210 in the vicinity of inner peripheral edge 225. In embodiments,the reinforcement members 260 may not extend laterally beyond innerperipheral edge 225 thereby maintaining a continuous and/oruninterrupted inner peripheral edge 225, as shown in FIGS. 2A-2C.

In addition to using reinforcement members, or as a substitute for thereinforcement members, the skirt sections may be formed by ultrasonicwelding or using adhesives to bond the skirt mesh layer 220 to firstmesh layer 210 at discreet locations such as those where a reinforcementmember would be positioned.

FIGS. 3A-3B illustrate a skirted hernia repair device 300 of the presentdisclosure wherein pocket 340 and/or skirt mesh layer 320 is by at leastone reinforcement member 360 a-d located in the vicinity of innerperipheral edge 325 to prevent skirt mesh layer 320 from inverting.Skirted hernia repair device 300 includes first mesh layer 310 suitablefor extending across a tissue opening and skirt mesh layer 320 having aninner peripheral edge 325 which defines opening 327. In FIG. 3A, outerperipheral edge 326 of skirt mesh layer 320 is attached to first meshlayer 310, but not along outer peripheral edge 316 of first mesh layer310 by seam or fold 330. Pocket 340 is formed between first mesh layer310 and skirt mesh layer 320, wherein pocket 340 extends from innerperipheral edge 325 of skirt mesh layer to seam 330 and/or outerperipheral edge 326 of skirt mesh layer 320.

In embodiments, as further depicted in FIG. 3A, skirted hernia repairdevice 300 may include a plurality of reinforcement members 360 a-d,non-symmetrically positioned around inner peripheral edge 325 of skirtmesh layer 320. In embodiments, as further depicted in FIG. 3A,reinforcement members 360 a-d may extend inwardly from skirt mesh layer320 over inner peripheral edge 325 and onto a surface of first meshlayer 310, thereby over-lapping both first mesh layer 310 and skirt meshlayer 320 intermittently along a portion of inner peripheral edge 325.

As depicted in FIG. 3B, reinforcement members 360 b, 360 d attach orconnect first mesh layer 310 to skirt mesh layer 320 in the vicinity ofinner peripheral edge 325. In embodiments, as further depicted in FIG.3B, reinforcement members 360 b, 360 d may be positioned on top of skirtmesh layer 320 and extend through pocket 340 to connect to first meshlayer 310. In embodiments, as further depicted in FIG. 3B, reinforcementmembers 360 may be polymeric tabs that may be formed on device 300 usingany suitable process including, but limited to, extrusion, molding,melt-processing, heat-pressing, ultrasonic, welding, sealing, fusing,and the like.

Still referring to FIGS. 3A and 3B, reinforcement members 360 a-d mayinclude a beveled or rounded surface 361 which can act as a guide todirect a fastening device (not shown) into pocket 340. It is envisionedthat in embodiments wherein the reinforcement member can also act as aguide for the fastening device, the likelihood of the fastening deviceentering the pocket may be increased. Also, the likelihood of a surgeonmistaking the reinforcement member for the seam may be decreased.

Turning now to FIGS. 4A-4B, a skirted hernia repair device 400 is shownwhich includes reinforcement members 460 a-d that extend from innerperipheral edge 425 to outer peripheral edge 426 of skirt mesh layer420. Similar to FIGS. 3A-3B, reinforcement members 460 a-d can act as aguide for the fastening device (not shown). However, since reinforcementmembers 460 a-d extend from inner peripheral edge 425 to outerperipheral edge 426, fastening device is more likely to enter thedeepest portion of pocket 440.

In embodiments, as depicted in FIG. 4B, reinforcement member 460 may bepositioned solely within pocket 440 and attach skirt mesh layer 420 tofirst mesh layer 410 without protruding from pocket 440. In embodiments,reinforcement member 460 may be an adhesive or sealant material which isplaced within pocket 440 and allowed to cure, set or harden therebyattaching skirt mesh layer 420 to first mesh layer 410 withoutdisrupting the topography of the outer surface of either layer. Skirtsection may also be formed by heat or ultrasonic welding the skirt meshlayer 420 to the first mesh layer 410 at discrete locations.

Any biocompatible material may be used to form the skirted hernia repairdevices described herein, including the first mesh layer, the skirt meshlayer and the reinforcement members. For example, the first mesh layerand the skirt mesh layer may be made from natural, synthetic,bioabsorbable and/or non-bioabsorbable materials. It should of course beunderstood that any combination of natural, synthetic, bioabsorbable andnon-bioabsorbable materials may be used to form the first mesh layer andthe skirt mesh layer described herein.

The term “bioabsorbable” as used herein is defined to include bothbiodegradable and bioresorbable materials. By bioabsorbable, it is meantthat the materials decompose, or lose structural integrity under bodyconditions (e.g. enzymatic degradation or hydrolysis) or are broken down(physically or chemically) under physiologic conditions in the body suchthat the degradation products are excretable or absorbable by the body.

Representative natural bioabsorbable materials include: polysaccharides,such as alginate, dextran, chitin, hyaluronic acid, cellulose, collagen,gelatin, fucans, glycosaminoglycans, and chemical derivatives thereof(substitutions and/or additions of chemical groups, for example, alkyl,alkylene, hydroxylations, oxidations, and other modifications routinelymade by those skilled in the art); and proteins, such as albumin,casein, zein, silk, and copolymers and blends thereof, alone or incombination with synthetic polymers.

Synthetically modified natural polymers include cellulose derivatives,such as alkyl celluloses, hydroxyalkyl celluloses, cellulose ethers,cellulose esters, nitrocelluloses, and chitosan. Examples of suitablecellulose derivatives include methyl cellulose, ethyl cellulose,hydroxypropyl cellulose, hydroxypropyl methyl cellulose, hydroxybutylmethyl cellulose, cellulose acetate, cellulose propionate, celluloseacetate butyrate, cellulose acetate phthalate, carboxymethyl cellulose,cellulose triacetate, and cellulose sulfate sodium salt. These arecollectively referred to herein as “celluloses.”

Representative synthetic bioabsorbable polymers include polyhydroxyacids prepared from lactone monomers, such as glycolide, lactide,caprolactone, ε-caprolactone, valerolactone, and δ-valerolactone, aswell as pluronics, carbonates (e.g., trimethylene carbonate,tetramethylene carbonate, and the like), dioxanones (e.g., 1,4-dioxanoneand p-dioxanone), 1,dioxepanones (e.g., 1,4-dioxepan-2-one and1,5-dioxepan-2-one), and combinations thereof. Polymers formed therefrominclude: polylactides; poly(lactic acid); polyglycolides; poly(glycolicacid); poly(trimethylene carbonate); poly(dioxanone);poly(hydroxybutyric acid); poly(hydroxyvaleric acid);poly(lactide-co-(ε-caprolactone-)); poly(glycolide-co-(ε-caprolactone));polycarbonates; poly(pseudo amino acids); poly(amino acids);poly(hydroxyalkanoate)s; polyalkylene oxalates; polyoxaesters;polyanhydrides; polyortho esters; and copolymers, block copolymers,homopolymers, blends, and combinations thereof. In certain embodiments,the first mesh layer and/or the skirt mesh layer may be formed using acombination of bioabsorbable and non-bioabsorbable polymers.

Some non-limiting examples of suitable non-bioabsorbable materialsinclude polyolefins, such as polyethylene and polypropylene includingatactic, isotactic, syndiotactic, and blends thereof; polyethyleneglycols; polyethylene oxides; ultra high molecular weight polyethylene;copolymers of polyethylene and polypropylene; polyisobutylene andethylene-alpha olefin copolymers; fluorinated polyolefins, such asfluoroethylenes, including expanded polytetrafluoroethylene (ePTFE) andcondensed polytetraflouroethylene c(PTFE), fluoropropylenes,fluoroPEGSs, and polytetrafluoroethylene; polyamides, such as nylon andpolycaprolactam; polyamines; polyimines; polyesters, such aspolyethylene terephthalate and polybutylene terephthalate; aliphaticpolyesters; polyethers; polyether-esters, such as polybutester;polytetramethylene ether glycol; 1,4-butanediol; polyurethanes; acrylicpolymers and copolymers; modacrylics; vinyl halide polymers andcopolymers, such as polyvinyl chloride; polyvinyl alcohols; polyvinylethers, such as polyvinyl methyl ether; polyvinylidene halides, such aspolyvinylidene fluoride and polyvinylidene chloride; polyacrylonitrile;polyaryletherketones; polyvinyl ketones; polyvinyl aromatics, such aspolystyrene; polyvinyl esters, such as polyvinyl acetate; copolymers ofvinyl monomers with each other and olefins, such as etheylene-methylmethacrylate copolymers, acrylonitrile-styrene copolymers, ABS resins,and ethylene-vinyl acetate copolymers; alkyd resins; polycarbonates;polyoxymethylenes; polyphosphazine; polyimides; epoxy resins; aramids,rayon; rayon-triacetate; spandex; silicones; and combinations thereof

The skirted hernia repair devices, including at least the first meshlayer and the skirt mesh layer, may be formed using any method withinthe purview of those skilled in the art. Some non-limiting examplesinclude, weaving, knitting, braiding, crocheting, extruding, spraying,casting, molding, and combinations thereof. In some embodiments, thefirst mesh layer and the skirt mesh layer may be a two or threedimensional surgical mesh which is woven, knitted, braided, or crochetedfrom at least one first filament to form the layer. The at least onefilament may be a monofilament or a multifilament.

In embodiments, the first mesh layer and the skirt mesh layer may beformed separately and combined along a seam using any suitable techniqueincluding weaving, knitting, braiding, crocheting, molding, suturing,welding, ultrasonics, gluing, and the like.

In embodiments, the first mesh layer and the skirt mesh layer may beinitially formed as a single layer of mesh which is folded inwardly nearthe outer perimeter of the single layer of mesh to form the skirt meshlayer. The folded skirted mesh may be further processed to maintain theskirt mesh next to the first mesh layer in an overlapping position nearthe outer peripheral edge of each layer. Examples include thermosetting,ultrasonics, welding, pressing, knitting, braiding, weaving, crochetingand the like.

As depicted in the figures provided herein, the surface area of thefirst mesh layer is greater than the surface area of the skirt meshlayer. However, when the surface area of the first mesh layer is atleast 1.5 times the surface area of the skirt mesh layer, the skirt meshlayer is more likely to be inverted during implantation and/or handling.In embodiments, the skirted hernia repair devices described hereininclude a first mesh layer having a surface area that is at least 1.5times the surface area of the skirt mesh layer. In embodiments, theskirted hernia repair devices described herein include a first meshlayer having a surface area that is at least twice the surface area ofthe skirt mesh layer.

The reinforcement members described herein may be made from anybiocompatible material, including the non-limiting exemplary list ofnatural, synthetic, bioabsorbable and/or non-bioabsorbable materialsprovided hereinabove. It should of course be understood that anycombination of natural, synthetic, bioabsorbable and non-bioabsorbablematerials may also be used to form the reinforcement members describedherein.

The reinforcement members of the skirted hernia repair devices describedherein may be formed using any method within the purview of thoseskilled in the art. Some non-limiting examples include, weaving,knitting, braiding, crocheting, extruding, spraying, dipping, casting,ultrasonics, welding, molding, and combinations thereof. In embodiments,the reinforcement members are filaments that fixedly attach the firstmesh layer and the skirt mesh layer in the vicinity of the innerperipheral edge and/or the pocket. In embodiments, the reinforcementmembers are polymeric materials or tabs that fixedly attach the firstmesh layer and the skirt mesh layer in the vicinity of the innerperipheral edge and/or the pocket. It is envisioned that a wide varietyof other mechanical fasteners or fixtures may also be suitable for useas the reinforcement members. For example, in embodiments, thereinforcement members may be two part mechanical fasteners which are notfixedly attached, but rather can optionally be unattached when needed,such as the use of snaps, buttons, magnets and the like. In suchembodiments, one part of the two part fastener may be positioned on thefirst mesh layer and the second part of the two-part fastener may bepositioned on the skirt mesh layer.

In embodiments, the skirted hernia repair device may include at leastone additional layer. For example, in embodiments, the skirted herniarepair device may further include an adhesion barrier film whichprevents the ingrowth of tissue between the barrier film and thelayer(s) of mesh material. In embodiments, as illustrated in FIG. 5, anadhesion barrier film 590 may be positioned on the second side 510 a ofthe first mesh layer 510, opposite the skirt mesh layer 520. Inembodiments, as illustrated in FIG. 6, an adhesion barrier film 690 maybe positioned on the outside of the skirt mesh layer 620, outside theskirted section 680. In still other embodiments, as illustrated in FIG.7, an adhesion barrier film 790 may be positioned within the skirtedsection 780 between the first mesh layer 710 and the skirt mesh layer720. Combinations of each of these embodiments are also envisioned.

Methods of using the skirted hernia repair devices are also described.In one embodiment, a method for repairing a tissue defect is describedwhich includes: providing a skirted hernia repair device, positioningthe skirted hernia repair device within a tissue defect such that afirst mesh layer extends across the defect; and, securing the skirtedhernia repair device to tissue. The skirted hernia repair deviceincludes a first mesh layer, a skirt mesh layer, and at least onereinforcement member that connects the first mesh layer to the skirtmesh layer to prevent the skirt mesh layer from inverting. The firstmesh layer includes a first side, a second side, and an outer peripheraledge. The skirt mesh layer is positioned on the first side of the firstmesh layer; the skirt mesh layer includes an inner peripheral edgedefining an opening. At least one reinforcement member that connects thefirst mesh layer to the skirt mesh layer to prevent the skirt mesh layerfrom inverting.

In another embodiment, a method for performing an intraperitoneal onlayprocedure is described which includes: providing a skirted hernia repairdevice, positioning the skirted hernia repair device within a tissuedefect such that a first mesh layer extends across the defect andoptionally, an adhesion barrier positioned beneath the first mesh layer;and, securing the skirted hernia repair device to tissue. Inembodiments, securing a skirt mesh layer of the skirted hernia repairdevice to the tissue. The skirted hernia repair device includes a firstmesh layer, a skirt mesh layer, and at least one reinforcement memberthat connects the first mesh layer to the skirt mesh layer to preventthe skirt mesh layer from inverting. The skirted hernia repair devicemay optionally include an adhesion barrier. The first mesh layerincludes a first side, a second side, and an outer peripheral edge. Theskirt mesh layer is positioned on the first side of the first meshlayer; the skirt mesh layer includes an inner peripheral edge definingan opening. At least one reinforcement member that connects the firstmesh layer to the skirt mesh layer to prevent the skirt mesh layer frominverting.

From the foregoing and with reference to the various figure drawings,those skilled in the art will appreciate that certain modifications canalso be made to the present disclosure without departing from the scopeof the same. While several embodiments of the disclosure have been shownin the drawings, it is not intended that the disclosure be limitedthereto, as it is intended that the disclosure be as broad in scope asthe art will allow and that the specification be read likewise.Therefore, the above description should not be construed as limiting,but merely as exemplifications of particular embodiments. Those skilledin the art will envision other modifications within the scope and spiritof the claims appended hereto.

1-13. (canceled)
 14. A method for repairing a tissue defect, the methodcomprising the steps of: positioning a skirted hernia repair devicewithin a tissue defect such that a first mesh layer of the skirtedhernia repair device extends across the tissue defect, the skirtedhernia repair device including: the first mesh layer having a firstside, a second side, and an outer peripheral edge; a skirt mesh layerpositioned on the first side of the first mesh layer forming a pockettherebetween, the skirt mesh layer having an inner peripheral edgedefining an opening in the skirt mesh layer; and, a plurality ofreinforcement members that connect the first mesh layer to the skirtmesh layer near the inner peripheral edge to prevent the skirt meshlayer from inverting; and, securing the skirted hernia repair device totissue.
 15. The method of claim 14, further comprising sliding afastening device laterally across the first side of the first mesh layerand into the pocket prior to securing the skirted hernia repair deviceto tissue.
 16. The method of claim 15, wherein securing the skirtedhernia repair device to tissue includes firing the fastening devicethrough the skirt mesh layer from inside the pocket.
 17. The method ofclaim 14, wherein securing the skirted hernia repair device to tissueincludes delivering a fastener in the vicinity of the pocket and throughthe device.
 18. The method of claim 14, wherein the plurality ofreinforcement members each include a polymeric tab extending from theskirt mesh layer inwardly towards a center of the first side of thefirst mesh layer over the inner peripheral edge and onto a portion ofthe first side of the first mesh layer inside the opening, wherein eachpolymeric tab includes an edge configured to guide a fastening deviceinto the pocket formed between the skirt mesh layer and the first meshlayer.
 19. The method of claim 14, wherein the plurality ofreinforcement members include a first pair of first and secondreinforcement members each having a first end extending from the innerperipheral edge of the skirt mesh layer to an outer peripheral edge ofskirt mesh layer, wherein the second ends of the first and secondreinforcement members of the first pair are closer to each other thanthe first ends of the first and second reinforcement members of thefirst pair.
 20. The method of claim 19, wherein the plurality ofreinforcement members further include a second pair of first and secondreinforcement members each having a first end extending from the innerperipheral edge of the skirt mesh layer to an outer peripheral edge ofskirt mesh layer, wherein the second ends of the first and secondreinforcement members of the second pair are closer to each other thanthe first ends of the first and second reinforcement members of thesecond pair.
 21. The method of claim 14, wherein the plurality ofreinforcement members include a plurality of distinct reinforcementmembers positioned intermittently around the inner peripheral edge, theplurality of reinforcement members fixedly attaching the first meshlayer to the skirt mesh layer to prevent the pocket from inverting,wherein the plurality of reinforcement members are free of the innerperipheral edge and free of the outer peripheral edge, wherein the skirtmesh layer is spaced apart from the first mesh layer along the pocketcreating a void therebetween, the void being positioned on both sides ofthe plurality of reinforcement members and extending to the opening. 22.The method of claim 14, wherein the skirted hernia repair device furthercomprises an adhesion barrier film positioned on the second side of thefirst mesh layer.
 23. The method of claim 14, wherein the skirted herniarepair device further comprises an adhesion barrier film positioned onan outer surface of the skirt mesh layer opposite the pocket.
 24. Themethod of claim 14, wherein the skirted hernia repair device furthercomprises an adhesion barrier film positioned on an inner surface of theskirt mesh layer and a portion of the first side of the first mesh layerinside the pocket.
 25. The method of claim 14, wherein the plurality ofreinforcement members are positioned within the pocket.
 26. The methodof claim 14, wherein the plurality of reinforcement members aresymmetrically positioned around the inner peripheral edge.
 27. Themethod of claim 14, wherein an outer peripheral edge of skirt mesh layeris aligned with an outer peripheral edge of the first mesh layer. 28.The method of claim 14, wherein the device includes only one singlepocket and the plurality of reinforcement members are positioned withthe one single pocket.
 29. The method of claim 14, wherein the firstmesh layer has a surface area that is at least 1.5 times larger than asurface area of the skirt mesh layer.
 30. The method of claim 14,wherein the first mesh layer is a three dimensional surgical mesh andthe skirt mesh layer is a two dimensional surgical mesh
 31. The methodof claim 14, wherein the method for repairing a tissue defect is anintraperitoneal onlay procedure.